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K Number
K041146
Device Name
CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
Manufacturer
CONTROL SOLUTIONS, INC.
Date Cleared
2004-06-08

(36 days)

Product Code
IPF
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K041140
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Relaxation of muscle spasm .
  • Increasing local blood circulation .
  • Maintaining or increasing range of motion •
  • Preventing or retarding disuse atrophy .
  • Muscle re-education .
  • Intusion is outcales. .
Device Description

CS3102 High Voltage Galvanic Stimulator

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called the "CS3102 High Voltage Galvanic Stimulator." It outlines the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices.

The document does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
  • Information about MRMC comparative effectiveness studies or standalone algorithm performance.
  • Details on how ground truth was established for training or test sets.

Therefore, I cannot fulfill your request based on the provided input.

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).